Phase 2
Completed N=212
Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.
Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Source: ClinicalTrials.gov NCT01750281 ↗
Enrolled (actual)
212
Serious AEs
44.6%
Results posted
Jul 2017
Primary outcomePrimary: Progression Free Survival (PFS) — 4.3; 3.0; 4.2 Months — p=0.584
Summary
The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
4.3; 3.0; 4.2 | 0.584 |
| SECONDARY Overall Survival (OS) |
11.5; 5.7; 7.7 | 0.126 |
Eligibility Criteria
Inclusion Criteria
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Male or female, aged 18 years or older
- Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
- Prospective confirmation of KRAS mutation negative status as determined via an AZ approved laboratory
- Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
Exclusion Criteria
- Mixed small cell and non-small cell lung cancer histology
- Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
- Other concomitant anti-cancer therapy agents except steroids
- Prior treatment with a MEK (Mitogen-Activated Protein Kinase) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable)
- The last radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment.
Data sourced from ClinicalTrials.gov (NCT01750281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.